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Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hearing aid model
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
  • Healthy outer ear.
  • Symmetrical hearing loss.
  • Ability to answer questions and repeat sentences.
  • Informed consent as documented by signature.
  • Willingness to wear different style of hearing aids.
  • Willingness to wear a binaural fitting.
  • Willingness to wear closed domes.
  • Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit

Exclusion Criteria:

  • Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
  • Limited mobility/not able to come to scheduled visits.
  • Inability to produce reliable hearing test result.
  • Visible congenital or traumatic deformity of the outer ear.
  • History of active drainage from the ear in the previous 90 days.
  • Abnormal appearance of the eardrum and ear canal.
  • Acute or chronic dizziness.
  • Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
  • Known psychological problems.

Sites / Locations

  • Unitron Hearing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hearing aid model

Arm Description

Unaided, Unitron RIC and Unitron BTE hearing aid styles during one-time visit.

Outcomes

Primary Outcome Measures

SNR-50
Obtain SNR-50 for each participant from the HINT for the three investigational conditions. Results from the unaided condition will be compared against each of the aided condition. No comparison will be done between aided conditions. It is expected for participants to have lower SNR scores (better) when wearing hearing aids than compared to unaided performance.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
May 3, 2022
Sponsor
Sonova AG
Collaborators
Sonova Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05197803
Brief Title
Clinical Study of Released Unitron RIC and BTE Hearing Aid Models
Official Title
Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Sonova Canada Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Participants will wear two sets of Unitron released hearing aids (RIC and BTE) programmed based on a prescriptive approach and will perform a standardized speech discrimination test in noise in both aided conditions as well as in unaided condition.
Detailed Description
During this study each participant will be asked to complete three randomized conditions of the HINT testing: unaided, aided with RIC, and aided with BTE. The investigators will be assessing their speech intelligibility in noise in each condition, during the same appointment to determine the SNR-50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
1 group with three randomized conditions (unaided, aided with RIC, aided with BTE).
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing aid model
Arm Type
Experimental
Arm Description
Unaided, Unitron RIC and Unitron BTE hearing aid styles during one-time visit.
Intervention Type
Device
Intervention Name(s)
Hearing aid model
Intervention Description
Amplification
Primary Outcome Measure Information:
Title
SNR-50
Description
Obtain SNR-50 for each participant from the HINT for the three investigational conditions. Results from the unaided condition will be compared against each of the aided condition. No comparison will be done between aided conditions. It is expected for participants to have lower SNR scores (better) when wearing hearing aids than compared to unaided performance.
Time Frame
2 hours appointment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (18+ years) with hearing impairment (N2 - N6 hearing loss). Healthy outer ear. Symmetrical hearing loss. Ability to answer questions and repeat sentences. Informed consent as documented by signature. Willingness to wear different style of hearing aids. Willingness to wear a binaural fitting. Willingness to wear closed domes. Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit Exclusion Criteria: Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product). Limited mobility/not able to come to scheduled visits. Inability to produce reliable hearing test result. Visible congenital or traumatic deformity of the outer ear. History of active drainage from the ear in the previous 90 days. Abnormal appearance of the eardrum and ear canal. Acute or chronic dizziness. Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Known psychological problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyu Qian, PhD
Organizational Affiliation
jinyu.qian@sonova.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unitron Hearing
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2E 1Y6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

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